The objective of this study is to evaluate the clinical impact of the NOL nociception level index monitoring on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort.
The study will assess the impact of intraoperative use of NOL nociception monitoring in in-hospital spine surgery procedures performed under general anesthesia on post operative patient outcomes. The study is designed as a quality improvement project with the prospective outcomes to be compared to a retrospective matched cohort. The objective of this study is to evaluate the clinical impact of the device on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort. The clinical impact will also be translated into economic metrics. Secondary endpoints 1. Reduction in time to extubation 2. Reduction in time to PACU discharge readiness 3. Reduction in anesthesia related adverse events: 1. PONV 2. Respiratory depression defined as respiratory rate (RR) below 8 respirations per minute (RPM) for 1 minute. Saturation of less than 90% for 1 minute under continuous monitoring 3. Somnolence 4. Sedation (Pasero score) 5. Discharge readiness (modified Aldrete score) 6. PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints INTRAOPERATIVE 1. Reduction in hemodynamic instability (hypertension, hypotensive events) 2. Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) 3. Association between time spent with NOL values above 25 and PACU pain intensity ratings WARD - up to 48 hours post surgery 1. Patient reported satisfaction levels using questionnaire QR15 2. Pain intensity (Time points: NRS according to the SOC)) 3. 48 hours post-operative opioid consumption 4. Requirement for Acute Pain Service consultation 5. Reduction in rescue opioid requirements 6. Ketamine prescription on the ward 7. Opioid prescription on the ward 8. PONV medication consumption 9. Clinician survey on the device
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The PMD-200 monitor with the NOL index will be used to guide analgesia dosing during anesthesia maintenance as an adjunct monitor used alongside other anesthesia monitors. If the NOL value is above 25 for sixty seconds or more, clinicians will evaluate whether more analgesia is needed. If the NOL value is below 25 the patient is considered to have adequately managed nociception.
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Total opioid requirement during surgery and PACU stay
Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)
Time frame: One day
Reduction in time to extubation
Reduction in time to extubation measured in minutes
Time frame: one day
Reduction in time to PACU discharge readiness
Reduction in time to PACU discharge readiness measured in minutes
Time frame: one day
Modified Aldrete Score
Modified Aldrete Score (scale of 0-10)
Time frame: one day
Reduction in PACU pain intensity rating
Reduction in PACU pain intensity rating (NRS scale of 0-10 )
Time frame: one day
Anesthesia Related Adverse Events - PONV
PONV in PACU assessed used accepted PONV symptom scale (0-4)
Time frame: 1 day
Anesthesia Related Adverse Events in PACU - Respiratory Depression
Respiratory depression defined as respiratory rate (RR) below 8 respirations per minute (RPM) for 1 minute. Saturation of less than 90% for 1 minute under continuous monitoring
Time frame: one day
Anesthesia Related Adverse Events in PACU - Sedation & Somnolence
Sedation \& Somnolence using Pasero Scale (S 1-4)
Time frame: one day
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